NA

Primary DI: 05056080501079
Brand: NA
Company: REMEL EUROPE LIMITED
Model: R30166001
Published: 2016-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

remel.com

Product Codes

Code	Name
GRP	Antisera, All Types, H. Influenza

Product Code Classifications

Code	Device	Specialty	Class
GRP	Antisera, All Types, H. Influenza	Microbiology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
05056080501079	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
05056080501079	05056080501079	5056080501079

GMDN Terms

Term	Definition
Haemophilus influenzae culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple strains of Haemophilus influenzae bacteria isolated by culture from a clinical specimen, using an agglutination method.

Sterilization Methods

Method

Contacts

Phone	Email
+4401322295600	ITechnicalSupport@remel.com

Regulatory Flags

DUNS number: 232600853
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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05056080501321	PathoDx Extraction Reagent 2 (7ml)	R62055	2021-07-21
05056080501338	PathoDx Extraction Reagent 2 (14ml)	R62057	2021-07-21
05056080501345	PathoDx Extraction Reagent 3	R62060	2021-07-21
05056080501352	PathoDx Strep Grouping Universal Kit (60 test)	R62076	2021-07-21
05056080501369	PathoDx Strep Grouping Universal Kit (120 test)	R62150	2021-07-21
05056080501376	Streptex	R30950501	2021-07-21
05056080501383	Streptex 200	R30164701	2021-07-21
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15060392376338	Mast Assure Antisera	MAST GROUP LIMITED	GRP	2021-09-22
04048474025309	Haemophilus influenza B IgG ELISA	DRG Instruments Gesellschaft mit beschränkter Haftung	GRP	2019-06-06
00404847425307	Haemophilus influenza B IgG ELISA	DRG Instruments Gesellschaft mit beschränkter Haftung	GRP	2019-06-06
15060392377564	Mast Assure Antisera	MAST GROUP LIMITED	GRP	2018-12-12
15060392377571	Mast Assure Antisera	MAST GROUP LIMITED	GRP	2018-08-17
07350049850115	Phadebact Haemophilus Test	Mkl Diagnostics AB	GRP	2016-11-17
05051700006767	VaccZyme™ Human Anti-Haemophilus Influenzae type b	THE BINDING SITE GROUP LIMITED	GRP	2016-09-24
05056080501086	NA	REMEL EUROPE LIMITED	GRP	2016-09-24
05056080501093	NA	REMEL EUROPE LIMITED	GRP	2016-09-24
05056080501109	NA	REMEL EUROPE LIMITED	GRP	2016-09-24
05056080501116	NA	REMEL EUROPE LIMITED	GRP	2016-09-24
05056080501123	NA	REMEL EUROPE LIMITED	GRP	2016-09-24
05713106034620	H. influenzae Type b serum, 1 mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106852057	ImmuLex H. influenzae type b antiserum, 1,5 mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106914601	ImmuLex H. influenzae type a antiserum, 1,5 mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106914618	ImmuLex H. influenzae type c antiserum, 1,5 mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106914625	ImmuLex H. influenzae type d antiserum, 1,5mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106914649	ImmuLex H. influenzae type e antiserum, 1,5mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106914656	ImmuLex H. influenzae type f antiserum, 1,5mL	Ssi Diagnostica A/S	GRP	2016-09-13
05713106914670	ImmuLex H. influenzae polyv. Antiserum, 1,5mL	Ssi Diagnostica A/S	GRP	2016-09-13
00382902223719	BD Difco™ Haemophilus Influenzae Antiserum Poly	BECTON, DICKINSON AND COMPANY	GRP	2016-07-07
00382902522607	BD Directigen™ H. influenzae type b Test Kit	BECTON, DICKINSON AND COMPANY	GRP	2016-05-19
00382902278917	BD Difco™ Haemophilus Influenzae Antiserum Type c	BECTON, DICKINSON AND COMPANY	GRP	2016-04-29
00382902279013	BD Difco™ Haemophilus Influenzae Antiserum Type d	BECTON, DICKINSON AND COMPANY	GRP	2016-04-29
00382902279112	BD Difco™ Haemophilus Influenzae Antiserum Type e	BECTON, DICKINSON AND COMPANY	GRP	2016-04-29
00382902279211	BD Difco™ Haemophilus Influenzae Antiserum Type f	BECTON, DICKINSON AND COMPANY	GRP	2016-04-29
00382902223610	BD Difco™ Haemophilus Influenzae Antiserum Type b	BECTON, DICKINSON AND COMPANY	GRP	2016-04-28
00382902225010	BD Difco™ Haemophilus Influenzae Antiserum Type a	BECTON, DICKINSON AND COMPANY	GRP	2016-04-28