Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Blood & Blood Products

Blood & Blood Products

                        Blood Grouping and Phenotyping Reagents
          Questions about Blood


                        Approved Blood Products
          Regulation of the Blood Supply Home
          Vaccines, Blood & Biologics
          Blood & Blood Products
          Blood Grouping and Phenotyping ReagentsBlood & Blood Products Blood Grouping and Phenotyping Reagents
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintLicensed Product Approval Information

(Listed in alphabetical order by Manufacturer)

MANUFACTURER
			STN
			TRADE NAME
			PRODUCT*Alba Bioscience Limited*
			*125599
			125600
			125601*
			*Blood Grouping Reagents (Human/Murine Monoclonal) Anti-C, Anti-e, and Anti-Cw*
			*ALBAclone Anti-C (Human/Murine Monoclonal), ALBAclone Anti-e, (Human/Murine Monoclonal), ALBAclone Anti-Cw (Human/Murine Monoclonal)*Alba Bioscience Limited
			125599
			Blood Grouping Reagents (Human/Murine Monoclonal) Anti-C
			ALBAclone Anti-C (Human/Murine Monoclonal)Alba Bioscience Limited
			125600
			Blood Grouping Reagents (Human/Murine Monoclonal) Anti-e
			ALBAclone Anti-e, (Human/Murine Monoclonal)Alba Bioscience Limited
			125601
			Blood Grouping Reagents (Human/Murine Monoclonal) Anti-Cw
			ALBAclone Anti-Cw (Human/Murine Monoclonal)*Alba Bioscience Limited, License #1807*
			*BL 125129
			BL 125130
			BL 125131
			BL 125134
			BL 125135
			BL 125136
			BL 125137
			BL 125138
			BL 125139
			BL 125140
			BL 125143
			BL 125144*
			*ALBAclone
			Anti-A (Murine Monoclonal)
			Anti-B (Murine Monoclonal)
			Anti-A,B (Murine Monoclonal)
			Anti-D (Monoclonal) (IgM)
			Anti-E
			Anti-c
			Anti-k
			Anti-M
			Anti-N (Murine Monoclonal)
			Anti-Le a (Murine Monoclonal)
			Anti-Le b (Murine Monoclonal)
			Anti-Lu b (Murine Monoclonal)
			Anti-D (Monoclonal) (IgM Blend)
			Anti-D (Monoclonal Blend)*
			*Blood Grouping Reagents**Alba Bioscience Inc, License #1723*
			*125129-125144*
			*ALBAclone*
			*Blood Grouping Reagents*Alba Bioscience Limited
			CAN'T FIDN LINK
			ALBAclone Anti-D fusion (Anti-D)Alba Bioscience Limited
			125463
			ALBAclone Anti- C3d (Murine Monoclonal)
			For Tube Technique
			Anti-Human Globulin (Murine Monoclonal)Alba Bioscience Limited
			125637
			ALBAclone Anti-Fyb (Human/Murine Monoclonal)
			For Tube Techniques
			Blood Grouping ReagentAlba Bioscience Limited
			125337
			ALBAcyte
			A1 Cells
			A2 Cells
			AB Cells
			Orr Cells
			Reagent Red Blood Cells
			for ABO Reverse GroupingAlba Bioscience Limited
			125464
			Anti-Human Globulin Anti-IgG (Rabbit)
			Anti-Human GlobulinAlba Bioscience Limited
			125465
			**Anti-Human Globulin
			Anti-IgG,** -C3d; Polyspecific (**Rabbit**/Murine Monoclonal) (Green)
			For Tube Technique
			Anti-Human Globulin (Rabbit/Murine Monoclonal)Alba Bioscience Limited, License #1807
			125440
			None
			Blood Grouping Reagent (For Further Manufacturing Use) Anti-c (H48) Human/Murine Monoclonal IgMAlba Bioscience Limited, License #1807
			125438
			None
			Blood Grouping Reagent, Anti-A (Murine Monoclonal) For Further Manufacturing Use (FFMU)Alba Bioscience Limited
			125341
			Blood Grouping Reagent, Anti-Fya
			ALBAsera
			For Indirect Antiglobulin Test by Tube Technique
			Blood Grouping Reagents, Anti-FyaAlba Bioscience Limited
			BL125342
			Blood Grouping Reagent, Anti-Fyb ALBAsera
			Anti-Fya (Monoclonal) (IgG)
			Anti-Fyb
			ORTHOTM Sera
			Blood Grouping Reagents, Anti-FybAlba Bioscience Limited
			125340
			Blood Grouping Reagent, Anti-K ALBAsera
			For Indirect Antiglobulin Test
			by Tube Technique
			Blood Grouping Reagent,  Anti-K ALBAseraAlba Bioscience Limited
			125345
			Blood Grouping Reagent, Anti-s ALBAsera
			For Indirect Antiglobulin Test
			by Tube Technique
			Blood Grouping Reagents, Anti-sAlba Bioscience Limited
			BL 125314
			BL 125567
			BL 125568
			BL 125569
			BL 125570
			BL 125571
			BL 125572
			BL 125573
			Blood Grouping Reagents, Anti-Jka, Anti-Jkb, Anti-K, Anti-P1, Anti-Fya, Anti-Fyb, Anti-S, Anti-s
			Anti-D (Monoclonal Blend)
			Anti-Fya (Monoclonal) (IgG)
			Anti-Jka (Monoclonal)
			Anti-Jkb (Monoclonal)
			Anti-S (Monoclonal) (IgG)
			Anti-s (Monoclonal) (IgG)
			Anti-K (Monoclonal)
			Anti-P1 (Murine Monoclonal)
			Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1Alba Bioscience Limited
			125343
			Anti-Wra ALBAsera
			Blood Grouping Reagents, Anti-Wra ALBAseraAlba Bioscience Limited (Alba)
			BL 125304-06
			125308-09
			125311-14
			125568-69
			125572-73
			125599 125600 125601 125637
			ORTHO Sera, ALBAclone
			Blood Grouping Reagents, , Anti-D, Anti-N, Anti-Lea, Anti-Leb, Anti-DAmerican National Red Cross
			BL 101728 – 34,
			103292
			Blood Grouping Regent
			N/ABio-Rad Medical Diagnostics GmbH
			125098
			Anti-Human Globulin Anti-IgG IH-Card AHG Anti-IgG
			Anti-Human Globulin (Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
			125529
			IH-Card AHG Anti-IgG,-C3d
			Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
			125532
			Blood Grouping Reagent, Anti-B (Murine Monoclonal) (IgG) (Formulated for Automated Testing)
			IH-CardBio-Rad Medical Diagnostics GmbH
			125533
			IH-Anti-D (RH1) Blend
			Blood Grouping Reagent, Anti-D (Monoclonal Blend) (Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
			BL 125094
			BL 125096
			BL 125097
			BL 125202
			BL 125203
			BL 125204
			BL 125205
			BL 125206
			BL 125208
			BL 125529
			BL 125532
			BL 125533
			IH-Card
			Anti-A (Murine Monoclonal)(Formulated for Automated Testing)
			Anti-A,B (Murine Monoclonal)(Formulated for Automated Testing)
			Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)
			Anti-E (Monoclonal)(Formulated for Automated Testing)
			Anti-e (Monoclonal)(Formulated for Automated Testing)
			Anti-K (Monoclonal)(Formulated for Automated Testing)
			Anti-c (Monoclonal)(Formulated for Automated Testing)
			Anti-C (Monoclonal)(Formulated for Automated Testing)
			Reagent Red Blood Cells For Use in Automated Systems
			Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing)
			Anti-B (Murine Monoclonal) (IgG)(Formulated for Automated Testing)
			Anti-D (Monoclonal Blend)(Formulated for Automated Testing)Bio-Rad Medical Diagnostics GmbH
			125208
			Reagent Red Blood Cells for use with the IH-System
			IH-Cell A1 & B, IH-Cell A2, IH-Cell I-II, IH-Cell I-II-III, IH-Cell Pool, IH-Panel 11, IH-Panel 11 Papain, IH-Panel Plus 6Biotest AG, License #1702
			BL 125098
			Anti-Human Globulin Solidscreen II
			Anti-Human GlobulinBiotest Medical Diagnostics GmbH, License #1798
			125207
			125208
			Biotestcell and Erytypecell
			Reagent Red Blood Cells Biotestcell A1 & B;
			Reagent Red Blood Cells Biotestcell A2;
			Reagent Red Blood Cells Biotestcell Pool;
			Reagent Red Blood Cells Biotestcell 1 & 2;
			Reagent Red Blood Cells Biotestcell 3;
			Reagent Red Blood Cells Biotestcell -I 8;
			Reagent Red Blood Cells Biotestcell -I 11;
			Reagent Red Blood Cells Biotestcell -I 11 Plus
			Reagent Red Blood Cells Erytypecell A1 & B;
			Reagent Red Blood Cells IH-Cell A1 & B
			Reagent Red Blood Cells IH-Cell A2 
			Reagent Red Blood Cells IH-Cell I-II
			Reagent Red Blood Cells IH-Cell I-II-III
			Reagent Red Blood Cells IH-Cell Pool
			Reagent Red Blood Cells IH-Panel 11
			Reagent Red Blood Cells IH-Panel 11 Papain
			Reagent Red Blood Cells IH-Panel Plus 6
			Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated SystemsBiotest Medical Diagnostics GmbH, License #1798
			BL 125097 - 125098
			Component of Erytype S
			Blood Grouping ReagentBiotest Medical Diagnostics GmbH, License #1798
			125202 - 125206;
			125218
			Erytype S
			Blood Grouping ReagentBiotest Medical Diagnostics GmbH
			125212
			Seraclone
			Blood Grouping Reagent Anti-Fya (Monoclonal)Biotest Medical Diagnostics GmbH
			125214
			Seraclone
			Blood Grouping Reagent Anti-s (Monoclonal)Biotest Medical Diagnostics GmbH
			125216
			Seraclone
			Blood Grouping Reagent Anti-S (Monoclonal)Biotest Medical Diagnostics GmbH
			BL 125094
			BL 125096
			BL 125097
			BL 125098
			BL 125202
			BL 125203
			BL 125204
			BL 125205
			BL 125206
			BL 125207
			BL 125208
			BL 125212
			BL 125213
			BL 125214
			BL 125216
			BL 125217
			BL 125219
			BL 125220
			BL 125221
			BL 125222
			BL 125223
			BL 125224
			BL 125225
			BL 125226
			BL 125227
			BL 125228
			BL 125229
			BL 125230
			BL 125231
			BL 125233
			BL 125529
			BL 125532
			BL 125533
			Blood Grouping Reagent IH-Card RhD(DVI-) + Phenotype
			Blood Grouping Reagent IH-Card Rh-Phenotype+K
			Blood Grouping Reagent IH-Card Anti-c
			Blood Grouping Reagent and Anti-Human Globulin Anti-IgG,-C3d; Polyspecific IH-Card ABO/RhD(DVI+)
			Blood Grouping Reagent IH-Card ABO/D(DVI-)+Rev A1,B
			Blood Grouping Reagent IH-Card ABO/D(DVI+)+Rev A1,B
			Blood Grouping Reagent IH-Card Group ABO
			Blood Grouping Reagent IH-Card ABD(DVI-)-Conf
			Blood Grouping Reagent IH-Card ABD(DVI+)-Conf
			Blood Grouping Reagent IH-Anti-D (RH1) Blend
			Seraclone Anti-Fya (FY1)
			Seraclone Anti-P1 (P1)
			Seraclone Anti-s (MNS4)
			Seraclone Anti-S (Monoclonal)
			Seraclone Anti-Jkb (Jk2)
			Seraclone Anti-A (ABO1)
			Seraclone Anti-B (ABO2)
			Seraclone Anti-A,B (ABO3)
			Seraclone Anti-D (RH1)
			Seraclone Anti-D (RH1) Blend
			Seraclone Anti-M (MNS1)
			Seraclone Anti-N (MNS2)
			Seraclone Anti-C (Monoclonal)
			Seraclone Anti-c (RH4)
			Seraclone Anti-E (RH3)
			Seraclone Anti-e (RH5)
			Seraclone Anti-K (KEL1)
			Seraclone Anti-Jka (JK1)
			Seraclone Anti-Lea (LE1)
			Seraclone Blood Grouping Reagents and Anti-Human Globulin ReagentsDIAGAST
			125707
			Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal
			Anti-Human Globulin (Murine Monoclonal) (For Further Manufacturing Use)DIAGAST
			125708
			Anti-Human Globulin Anti-IgG, -C3d FFMU, Rabbit Polyclonal/Murine Monoclonal
			Anti-Human Globulin (Rabbit/Murine Monoclonal) (For Further Manufacturing Use)
			Anti-Human Globulin (Rabbit/Murine Monoclonal) (For Further Manufacturing Use)DIAGAST, License #1887
			125439
			N/A
			Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Furthering Manufacturing Use) (FFMU)DIAGAST, License #1887
			125435
			N/A
			Blood Grouping Reagent, Anti-B (Murine Monoclonal) (For Further Manufacturing Use)(FFMU)DIAGAST, License #1887
			125442
			N/A
			Blood Grouping Reagent, Anti-D (Human Monoclonal) (For Further Manufacturing) (FFMU)DIAGAST, License #1887
			125443
			N/A
			Blood Grouping Reagent, Anti-E (Human Monoclonal) (FFMU)DIAGAST
			125617,
			125629 - 125636
			N/A
			Blood Grouping Reagents Anti-Fya (FY1), Anti-S (MNS3), Anti-s (MNS4)  Anti-Fyb (FY2), Anti-Jka (JK1) / Anti-Jkb (JK2), Anti-M (MNS1), ANTI-P1, Anti-Lea (LE1) / Anti-Leb (LE2),  Anti-D (RH1) IgG ,Anti-D (RH1) IgM, Anti-D (RH1) IgM/IgG , Anti-A (ABO1), Anti-B (ABO2),Anti-A,B (ABO3)DIAGAST
			125615, 125619 - 125626
			Blood Grouping Reagents
			Anti-A (ABO1), Anti-B (ABO2), Anti-A,B (ABO3), Anti-D (RH1) IgG, Anti-D (RH1) IgM, Anti-D (RH1) IgM/IgG, Anti-C (RH2), Anti-c (RH4),Anti-E (RH3),Anti-e (RH5),Anti-K (KEL1)DIAGAST
			125616
			N/A
			Blood Grouping Reagents Anti Human Globulin Anti-IgG, C3dDIAGAST
			125618,
			125627,
			125628
			N/A
			Blood Grouping Reagents Anti-Fya (FY1), Anti-S (MNS3), Anti-s (MNS4), Anti-Fyb (FY2),Anti-Jka (JK1)/Anti-Jkb (JK2), Anti-M (MNS1), ANTI-P1, Anti-Lea (LE1)/Anti-Leb (LE2)DIAGAST
			125168 - 125177,
			125187
			Blood Grouping Reagents
			OLYMPUS PK System Blood Grouping and Phenotyping ReagentsDiagnostic Grifols, S.A.
			125711
			DG Gel 8 Direct Coombs (Anti-C3d)
			Anti-Human Globulin (Murine Monoclonal)Diagnostic Grifols, S.A.
			125705
			DG Gel 8 Direct Coombs (Anti-IgG,-C3d)
			Anti-Human Globulin (Rabbit/Murine Monoclonal)Diagnostic Grifols, S.A.
			125445,
			125449,
			125450,
			125451,
			125452,
			125453,
			125454,
			125455,
			125456,
			125457
			DG Gel Cards
			Blood Grouping Reagent Combination KitImmucor, Inc, License #0886
			BL 102692
			N/A
			Anti-B (Murine Monoclonal)Immucor, Inc.
			BL 125686
			Blood Grouping Reagent (Monoclonal), Anti-Fyb
			N/AImmucor, Inc.
			125489- 125493
			N/A
			Blood Grouping Reagents (monoclonal), Anti-Jka (Monoclonal), Anti-Jkb (Monoclonal) Gamma-clone, Anti-S, Anti-s and Anti-Fya (IgG)Immucor, Inc.
			125688
			Blood Grouping Reagent (Monoclonal), Anti-k
			N/AImmucor, Inc.
			102707
			REFERENCELLS
			Reagent Red Blood CellsMedion Diagnostics AG, License #1740
			103898
			Data- Cyte Plus, Reverse-Cyte, Search-Cyte Pool 0.8% Reagent Red Blood Cells
			Reagent Red Blood CellsMicro Typing Systems, Inc
			103756
			MTS A/B
			MTS A/B/D
			MTS A/B/D/Reverse
			MTS Monoclonal Rh Phenotype Card
			Blood Grouping Reagent Combination KitMillipore (UK) Ltd.
			125497 125498
			N/A
			Blood Grouping Reagents (monoclonal), Anti-s and Anti-Fya (IgG)Siwa Biotech Corp
			125664
			Anti-Fya (Murine Monoclonal) (Recombinant).
			Blood Grouping ReagentSiwa Biotech Corp
			125665
			Anti-Fyb (Murine Monoclonal) (Recombinant).
			Blood Grouping Reagent

                                                                                  Content current as of:
      02/09/2023
              
              
Regulated Product(s)
		 BiologicsBlood & Blood Products

          
                        Blood Grouping and Phenotyping Reagents
          Questions about Blood


                        Approved Blood Products
          Regulation of the Blood Supply
 Subscribe for CBER Updates
                        Get e-mail updates on What’s New at CBER!
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop